Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh

This study has been completed.
Sponsor:
Collaborator:
D.med
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01775293
First received: January 22, 2013
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The aim of this study is to evaluate the efficacy and safety of the investigational device, RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.

Study hypothesis

  • level of significance: alpha=0.05( two-side)
  • power of test: (power= 1-beta),power=0.08
  • H0: P equals P0
  • H1: P unequals P0
  • The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)

Condition Intervention
Nasolabial Fold
Device: Non-absorbable polypropylene mesh

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi Center, Non-comparative Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety After Rhytidectomy Using Non-absorbable Mesh(RPM)

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration [ Time Frame: change in the WSRS from baseline at7 week ] [ Designated as safety issue: No ]

    The efficacy is assessed by the severity of the fold determined by the WSRS assessed by the investigator with photos WSRS(Wrinkle Severity Rating Scale)is be evaluated from 1 to 5 according to the severity of wrinkles

    (1= no visible fold, 5= extremely deep and long fold)



Secondary Outcome Measures:
  • The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration [ Time Frame: Changes Satisfaction from baseline at 7week ] [ Designated as safety issue: No ]
    The changes in the satisfaction(VAS-visual analog scale) of the pre and post rhytidectomy from baseline at 7week after administration VAS(visual analog scale)is to be evaluated from 0 to 100 by the participant ( 0= no wrinkle, 100= severe wrinkle)


Enrollment: 28
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-absorbable polypropylene mesh

2 step procedures

  • first step is insertion of Non-absorbable polypropylene mesh under the facial skin
  • second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step
Device: Non-absorbable polypropylene mesh

2 step procedures

  • first step is insertion of Non-absorbable polypropylene mesh under the facial skin
  • second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step

Detailed Description:

1. Benefits

  • enhancing self-satisfaction and quality of life by improving skin elasticity and correcting folds in the nasolabial fold area 2. Risks
  • erythema, swelling, pain and redness in the facial area generally resolve in 1 week 3.Duration of study
  • entire duration: approximate 36weeks
  • Follow-up period: 7 weeks
  • Enrollment period: 12 weeks 4. study design
  • 2 step operation process

    • First step- insert polypropylene mesh under the skin
    • Second step- pull the polypropylene mesh 3 weeks later
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who had soft tissue sagging around nasolabial fold
  • Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS)
  • Subjects who voluntary decided to participate in the study and signed the informed consent

Exclusion Criteria:

  • Subjects who have a skin disease on the face
  • Subjects who have severe facial skin disease
  • Subjects who are constantly taking anti-coagulants including aspirin
  • Subjects who have too thin or thick skin
  • Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease
  • Subjects who had an allergy to non-absorbable material.
  • Subjects who are taking immune suppressants
  • General weakness status
  • Pregnant or lactating women
  • Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease,
  • Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face
  • Subjects who participated in other clinical trial within 30 days from screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775293

Locations
Korea, Republic of
Korea University Anam Hospital
Seoul, Seongbukgu/Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Seoul National University Hospital
D.med
Investigators
Principal Investigator: Chanyeong Heo, Master Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01775293     History of Changes
Other Study ID Numbers: E-1209-170-002, 06-2012-208
Study First Received: January 22, 2013
Last Updated: January 6, 2014
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
Non-absorbable polypropylene mesh
WSRS
Rhytidectomy

ClinicalTrials.gov processed this record on October 21, 2014